InCarda Therapeutics has demonstrated promising results in developing FlecIH-103, an inhaled solution for converting paroxysmal atrial fibrillation (PAF) to sinus rhythm.
Though prematurely terminated, the Phase 3 RESTORE-1 trial showed that inhaled flecainide achieved a statistically significant cardioversion rate of 31% in PAF patients compared to placebo. The median time to restore normal sinus rhythm was approximately 13 minutes.
Despite the low enrollment, the study revealed significant pharmacoeconomic benefits associated with FlecIH-103. Patients who converted to sinus rhythm were more likely to be discharged within two hours and experienced better symptom resolution within 90 minutes. The need for electrical cardioversion was also reduced in the treatment arm.
The company is transitioning to a new drug-delivery platform supported by in vitro and Phase 1 clinical data. Phase 1 results warrant the continuation of the study, potentially advancing FlecIH-103 into registrational trials.
The conclusion of the RESTORE-1 trial provides evidence of the potential of inhaled flecainide as a safe and effective therapy for PAF patients, offering rapid restoration of sinus rhythm and reducing the need for invasive procedures.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
